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510(k) Data Aggregation
(125 days)
The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
The Stryker Universal Neuro 3 System is designed for a wide selection of solutions for cranial fixation. It consists of an implant module (a storage module that contains various versions and shapes of plates and screws) for the respective anatomical and indicated areas. The low profile plates of the Stryker Universal Neuro 3 System provide rigid fixation of cranial flaps with decreased palpability. There is a comprehensive selection of burr hole covers, straight plates, gap plates, 3D-plates, shunt plates, and box plates to provide many fixation options. The malleable plates can be easily contoured by hand without instruments. The pre-shaped skull-base plates provide covers for standard craniectomies, obviating the need to cut or trim mesh.
The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization, and/or rigid fixation of non-load-bearing bony areas subsequent to craniotomy, craniectomy, and cranial fractures in adults and adolescents (age 12 and higher).
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 (biological evaluation), ISO 10993-12 (sample preparation), ISO 10993-18 (chemical characterization). | Materials used are rated biocompatible according to ISO 10993-1. Cytotoxicity testing was performed according to ISO 10993-1, 10993-12, and 10993-18. |
| Corrosion Resistance | Demonstrated corrosion resistance of all components. | The corrosion resistance of all Neuro 3 screws, plates, and meshes were demonstrated. |
| Bending Stability | Plates (GWO) and burr hole covers (GXR) must pass the Lerch test according to ASTM F 382-99. | The bending stability of the Universal Neuro 3 plates (GWO) and burr hole covers (GXR) were tested by following ASTM F 382-99. The Lerch test was passed by all plates. |
| Screw Performance | Screws (HBW) must meet ASTM F 543 standards for metallic medical bone screws, including torque, depth, and angle measurements. | Testing was performed via ASTM F 543. Torque, depth, and angle were measured. The screws passed the automated insertion test. |
| Fixation Stability | Screws must demonstrate pull-out safety. | Pull-out safety testing was performed utilizing ASTM F 543. All acceptance criteria were met. |
| Retention Force | The retention force between the screw and the screwdriver blade must meet acceptance criteria. | Retention force between the screw and the screwdriver blade was tested utilizing ASTM F 543. All acceptance criteria were met. |
| Substantial Equivalence | Demonstrated substantial equivalence to identified predicate devices (Stryker Universal Neuro 2 System, Stryker Micro Dynamic Mesh, Synthes Neuro Plate and Screw System, KLS-Martin Micro Osteosynthesis System). | The Stryker Universal Neuro 3 System was verified and validated according to Stryker procedures. It was found substantially equivalent to predicate devices, sharing material composition, operating principles, and similar intended use (with the addition of adolescent use). Minor differences in dimensions and shapes were addressed. |
2. Sample sizes used for the test set and the data provenance
The document does not specify exact "sample sizes" in terms of number of devices tested for each performance criterion. Instead, it refers to testing of "all plates," "the screws," and "all Neuro 3 screws, plates and meshes." This implies that a sufficient number of samples were tested to demonstrate compliance with the referenced ASTM and ISO standards for the representative product configurations.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests were conducted according to recognized international (ISO) and US (ASTM) standards, suggesting the testing was performed in a controlled laboratory environment to demonstrate compliance. Given the context of a 510(k) submission, this testing would be prospective and specifically conducted for regulatory approval.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The testing for the Stryker Universal Neuro 3 System involves mechanical and material property evaluations against established engineering standards (ASTM, ISO), not clinical assessment requiring expert interpretation of data or images. Therefore, there is no "ground truth" to be established by experts in a clinical sense.
4. Adjudication method for the test set
This information is not applicable for the reasons stated above. Adjudication methods are typically used in studies involving subjective interpretation, such as clinical trials or image-based diagnostic assessments.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC comparative effectiveness study done. This device is a passive implant (craniofacial plates, burr hole covers, and screws) and does not involve AI or human "readers" in its function or evaluation for regulatory submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
There was no standalone (algorithm only) performance study done. This device is a physical medical implant and does not involve any algorithms or software for its primary function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance evaluation is based on established engineering standards and material specifications. For example:
- Biocompatibility: Conformance to ISO 10993 series.
- Mechanical Properties: Conformance to ASTM F 382-99 for bending stability (Lerch test) and ASTM F 543 for screw performance (torque, depth, angle, pull-out safety, retention force).
- Material Composition: Commercially Pure Titanium (Grade II, IV) and Titanium Alloy (Grade V), which are well-defined materials with known properties.
These standards and specifications serve as the objective "ground truth" against which the device's performance is measured.
8. The sample size for the training set
There is no training set for this device. As a passive mechanical implant, it does not involve machine learning or AI models that require training data.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set or ground truth established for a training set for this device.
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